Active Ingredient
Active Ingredient: Flurbiprofen 33mg
Antiphlamine Pain Relieving
FDA Label NDC 69642-1300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hanul Trading Co., Ltd. for the product Antiphlamine Pain Relieving (NDC 69642-1300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients: Methylparaben, Propylparaben, L-menthol, Propylene Glycol, Glycerin, Titanium Oxide, Kaolin, Sodium Carboxymethyl Cellulose, Dihydroxyaluminum Aminoacetate Hydrate, Disodium Edetate Hydrate, Gelatin, Sodium Polyacrylate, Polyacrylic Acid solution, Ferric Oxide, Butylhydroxytoluene, Purified water, felt, attachment felt, Polyethyleneterephthalate Separator, propyleneglycol monocaprylate, Sorbitan Oleate, tartaric acid
Purpose
Purpose: Topical Analgesic
Warnings
Warnings: For external use only Ask a doctor before use if you have redness over the affected area. Do not use: on wounds or damaged skin. Stop use and ask a doctor if excessive skin irritation occurs. Do not use if you are pregnant or breast feading. Do not use if you are allergic to any of the ingredients(Aspirin, Flurbiprofen) and stop use if rash, itching or allergic reaction develops.
Keep Out Of Reach Of Children
Keep out of reach of children: Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately. Children under 12 years of age: Ask a doctor Children under 30 month: Do not use
Indications & Usage
Indications & Usage: For the temporary relief of Shoulder Pain, Backache, Neuralgia, Arthralgia, Sore Muscles, Sprains, Bruises, Rheumatic Pain, and Fracture Pain.
Dosage & Administration
Dosage & Administration: Attach to the affected part, twice daily
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